Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks

adherence, defined by continuous and dichotomous measure

ARV drug resistance

Original Secondary Outcome Measures ICMJE

Not Provided

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected People in Wenxi County, Shanxi Province, China

Official Title ICMJE

A Feasibility Study of Lamivudine/Zidovudine (3TC/ZDV) Plus Efavirenz (EFV) as Initial Therapy of HIV-1 Infected Patients in a Rural Area of China

Brief Summary

The purpose of this study is to determine the safety, effectiveness, and tolerability of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected people in Wenxi County, Shanxi Province, China.

Detailed Description

HIV infection in China has reached epidemic proportions, especially in poor rural communities. Among the infected are former commercial plasma donors who became infected through contaminated blood collection equipment. This study will evaluate the safety, efficacy, and tolerability of an antiretroviral (ARV) regimen given to treatment-naive HIV infected adults. Participants will be recruited in Wenxi County, Shanxi Province.

This study will last 1 year. At study entry, all study participants will be given an ARV regimen consisting of lamivudine/zidovudine twice daily and efavirenz once daily. There will be 11 study visits; a physical exam, blood collection, and vital signs measurement will occur at all study visits. Participants will also receive safe sex and adherence counseling at all visits. Participants will be asked to complete an adherence questionnaire and will have their pills counted at most visits.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Estimated Enrollment ICMJE

100

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

HIV infected

Antiretroviral naive

CD4 count of less than 350 cells/mm3 within 30 days of study entry

Willing to use acceptable forms of contraception

Willing to stay in the study area for the duration of the study

Willing to not consume traditional Chinese medicines for the duration of the study

Willing to adhere to the follow-up study schedule

Exclusion Criteria:

Presence of an acute serious medical illness within 14 days prior to study entry. Participants with recently diagnosed opportunistic infections (except tuberculosis [TB]) and are stable on therapy for more than 30 days are eligible.

Current pancreatitis

Require certain medications

Pregnant or breastfeeding

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ICMJE

NCT00100594

Other Study ID Numbers ICMJE

CIPRA CH 004

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ICMJE

Not Provided

Investigators ICMJE

Study Chair:

Yunzhen Cao, MD

The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College